Manager Manufacturing

The Shop Floor Manager will be responsible for but not limited to:

Ensure safe working environment:

Ensure all procedures are followed that ensure safety.

Ensuring all required PPE is wore by personnel and is available, for example safety shoes, safety glasses, face shields, gloves, ear plugs, etc.

Knowledge of all hazardous materials used in the area and know where MSDS sheets are located and ensure personnel know the hazards.

Accountable to designate a Fire Wardens, Safety Correspondents, and Hazardous Waste Managers

Ensuring everyone is trained on evacuations plans.

Participate and ensure personnel participate in the site Safety Programs, for example SOR and PASS.

Maintain housekeeping / organization within the areas of responsibility.

Report all Safety incidents and near misses must be reported and communicated using defined formats.

Investigate safety incidents fully, implementing permanent fixes to prevent reoccurrence, and documenting the investigation in Trackwise

Ensure personnel go to health center when required. Ensure vaccinations, live area monitoring, and physicals are completed.

Maintain communication with HSE within the PC/APC Process

Accountable for the Quality and cGMP compliance:

Maintaining and understand of FDA and CQR expectations and ensuring those requirements are followed.

Communicate areas for cGMP improvement in all areas to Management.

Complete document approval and ensuring the overall document accuracy during approval and review.

Complete Batch Record reviews, which include completing section reviews within 24 hours of execution, communicate and remediate entry errors, enter PDW data.

Log deviations on the Shop Floor when the issue occurs, completing manager reviews, communicating all deviations to shift for those impacting area, assisting Principle Investigator’s in Root Cause Analysis and Preventative Action Implementation .

Proactive coach and support the technicians on the floor (an average of 6-7 hours per day).

Maintaining an understand FDA and CQR expectations and requirements.

Ensure areas of responsibility are ready for FDA audits, be aware of previous 483 observations .

Ensure technicians fully understand and use SWI on the manufacturing floor

Complete log book reviews in a timely manner.

Complete real time release of loads in Service / Buffer / Prep.

Ensure that all SWI books are compliant.

Lead complete action items on time, assign action items to appropriate support functions.

Ensure the following tasks are completed and compliant, Daily Release, Area Release, Area Cleanings, process and environmental sampling.

The Shop Floor Manager will be accountable for Productivity:

Manage activities to ensure optimal process schedule.

Communicate shift change reports to incoming shift.

Ensure equipment availability and process support.

Understand and support Department production requirements, for example Supply, Cycle Times, COGS.

Effectively schedule maintenance, PM completion, new equipment introduction.

Ensure personnel have what they need to perform their job.

Identify continuous improvement opportunities.

The Shop Floor Manager will “Take Care of Your People” by:

Understand company policies and procedures and adherence to Policies & Procedures.

Ensure personnel have what they need to perform their job.

Treat all People fairly and with dignity and respect at all times.

Complete on the floor coaching.

Complete 1:1 review forms with personnel, development planning, define succession planning for critical roles.

Documentation of personnel issues, behavior expectations.

Proactively manage vacation requests and back fill requirements.

Ensure training plans and cross training expectations are delivered shift personnel.

Complete payroll and leave of absence processes; proactively approve all requests / needs, accurate Ceridian record keeping.

Review data for consistency across personnel, absenteeism, etc.

Monitor, post changes on personnel schedule and sign.

Communicate with HR.

The Shop Floor Manager will provide managerial coverage for employees as required during non-standard working hours, e.g., weekends, and second/third shifts, in alternate departments. This position will participate in variable time.

This is a second shift position

The ideal candidate will possess:

Excellent verbal and written communication skills.

Working knowledge of SAP

Qualifications

Education:

BS degree in Biological Science or equivalent relevant

Required:

Experience in manufacturing and /or filling of pharmaceutical products.

Minimum of 5 years’ experience in manufacturing and or development departments

Experience working with a production department of pharmaceutical company.

Working knowledge of cGMP's.

Knowledge of continuous improvement

All your information will be kept confidential according to EEO guidelines.

Direct Staffing Inc